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Atrial FibrillationPPG-AFNCT05333380

Study on the Effectiveness of AF Analysis Software in AF Rhythm Monitoring

An observational study of Atrial Fibrillation and Atrial Fibrillation Paroxysmal, run by Beijing Anzhen Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. ECG is the most commonly used gold standard for clinical diagnosis of arrhythmias, but conventional ECG examinations are not adequate for long-term ECG follow-up measurements in… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
ECG/PPG monitoring
Type of treatment
Medical device
How many people
266 participants
Where
2 sitesChina
Study dates
29 Aug 2022to Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: Patients with atrial fibrillation who were hospitalized in the Department of Cardiology, Beijing Anzhen Hospital, aged from 18 to 80,were included in the study.

Who may be able to join

  • Be at least 18 years of age.
  • Have clear ECG-recorded atrial fibrillation in the past and will undergo atrial fibrillation ablation in the current hospitalization.
  • Patients who agree to wear both the watch and the ECG recorder.

Who cannot join

  • Inability to wear the watch due to limited mobility or other problems.
  • Severe skin diseases such as skin allergies or skin ulcers.
  • Chronic insomnia not treated with medication.
  • Patients with severe cardiovascular disease who may be resuscitated at any time.
  • Previous history of Parkinson's, schizophrenia, epilepsy.
  • Black people and those with excessively dark skin.

Trial locations and contacts

2 sites in 1 country.

Chang Sh Ma, Dr. contact

86-010-64412431

chshma@vip.sina.com

China2 sites, 2 recruiting

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality

    Chang Yi Li, MD, PhD

    Recruiting

  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality

    Song Zuo, MD,PhD

    Recruiting

Other trials in China

About this study

Official title: Study on the Effectiveness of Atrial Fibrillation Analysis Software in Atrial Fibrillation Rhythm Monitoring

Atrial fibrillation (AF) is a serious public health problem because of its increasing incidence and prevalence in the aging population. ECG is the most commonly used gold standard for clinical diagnosis of arrhythmias, but conventional ECG examinations are not adequate for long-term ECG follow-up measurements in patients with AF.

In this study, the AF patients will wear an watch and ECG patch to continuously monitor ECG and PPG. The software uses an integrated diagnostic mechanism of "AF burden + AF segments" to efficiently analyze ECG and PPG data, which can quickly and accurately identify the occurrence of AF and analyze AF burden in real-time, facilitating physicians' diagnosis and treatment and efficacy assessment.

Read the detailed description

PPG-AF study is a Cohort randomized observational study.The trial will include patients with AF who meet the study requirements from Beijing Anzhen Hospital within 2 months. Each participant will wear an watch and ECG monitor after admission to hospital until Radiofrequency ablation for AF, and after AF ablation until discharge. And more than 18 hours in each period.

  1. Primary endpoint. The ECG and PPG data are automatically analyzed by the AF analysis software. The results are compared with expert-annotated gold standard results to verify the sensitivity and specificity.
  2. Secondary endpoints. The AF burden calculated from PPG data is compared with that from ECG monitoring, to verify the feasibility of daily monitoring of AF burden using PPG analysis.
Being tested
ECG/PPG monitoring
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECG/PPG monitoringDevice

    The enrolled patients will wear an "ECG patch" and watch at the same time to collect ECG and PPG data respectively. The data collection time is from the day of hospitalization to before the ablation operation, and from 2 hours after the removal of ECG monitoring equipment to before leaving the hospital. The monitoring duration of each patient shall not be less than 18 hours.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The ECG and PPG data are automatically analyzed by the AF analysis software.

    The results are compared with expert-annotated gold standard results to verify the sensitivity and specificity.

    Measured: Two months after enrollment of the first subject

Secondary outcomes (1)

  1. The AF burden calculated from PPG data is compared with that from ECG monitoring.

    The AF burden calculated from PPG data is compared with that from ECG monitoring, to verify the feasibility of daily monitoring of AF burden using PPG analysis.

    Measured: Two months after enrollment of the first subject

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2022
  2. Study start29 Aug 2022
  3. Primary completionJun 2023 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05333380
Sponsor's protocol ID
2022-PPG-AF
Acronym
PPG-AF
Status last verified
Oct 2022
First submitted
1 Apr 2022
Last updated
14 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.

    PubMed 25520374

  • Wang Z, Chen Z, Wang X, Zhang L, Li S, Tian Y, Shao L, Hu H, Gao R; for China Hypertension Survey Group. The Disease Burden of Atrial Fibrillation in China from a National Cross-sectional Survey. Am J Cardiol. 2018 Sep 1;122(5):793-798. doi: 10.1016/j.amjcard.2018.05.015. Epub 2018 Jun 2.

    PubMed 30049467

  • Andrew NE, Thrift AG, Cadilhac DA. The prevalence, impact and economic implications of atrial fibrillation in stroke: what progress has been made? Neuroepidemiology. 2013;40(4):227-39. doi: 10.1159/000343667. Epub 2013 Jan 24.

    PubMed 23364221

  • Marini C, De Santis F, Sacco S, Russo T, Olivieri L, Totaro R, Carolei A. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005 Jun;36(6):1115-9. doi: 10.1161/01.STR.0000166053.83476.4a. Epub 2005 May 5.

    PubMed 15879330

  • Witassek F, Springer A, Adam L, Aeschbacher S, Beer JH, Blum S, Bonati LH, Conen D, Kobza R, Kuhne M, Moschovitis G, Osswald S, Rodondi N, Sticherling C, Szucs T, Schwenkglenks M; Swiss-AF study investigators. Health-related quality of life in patients with atrial fibrillation: The role of symptoms, comorbidities, and the type of atrial fibrillation. PLoS One. 2019 Dec 23;14(12):e0226730. doi: 10.1371/journal.pone.0226730. eCollection 2019.

    PubMed 31869399

  • McManus DD, Lee J, Maitas O, Esa N, Pidikiti R, Carlucci A, Harrington J, Mick E, Chon KH. A novel application for the detection of an irregular pulse using an iPhone 4S in patients with atrial fibrillation. Heart Rhythm. 2013 Mar;10(3):315-9. doi: 10.1016/j.hrthm.2012.12.001. Epub 2012 Dec 6.

    PubMed 23220686

  • Freedman B, Camm J, Calkins H, Healey JS, Rosenqvist M, Wang J, Albert CM, Anderson CS, Antoniou S, Benjamin EJ, Boriani G, Brachmann J, Brandes A, Chao TF, Conen D, Engdahl J, Fauchier L, Fitzmaurice DA, Friberg L, Gersh BJ, Gladstone DJ, Glotzer TV, Gwynne K, Hankey GJ, Harbison J, Hillis GS, Hills MT, Kamel H, Kirchhof P, Kowey PR, Krieger D, Lee VWY, Levin LA, Lip GYH, Lobban T, Lowres N, Mairesse GH, Martinez C, Neubeck L, Orchard J, Piccini JP, Poppe K, Potpara TS, Puererfellner H, Rienstra M, Sandhu RK, Schnabel RB, Siu CW, Steinhubl S, Svendsen JH, Svennberg E, Themistoclakis S, Tieleman RG, Turakhia MP, Tveit A, Uittenbogaart SB, Van Gelder IC, Verma A, Wachter R, Yan BP; AF-Screen Collaborators. Screening for Atrial Fibrillation: A Report of the AF-SCREEN International Collaboration. Circulation. 2017 May 9;135(19):1851-1867. doi: 10.1161/CIRCULATIONAHA.116.026693.

    PubMed 28483832

  • Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.

    PubMed 31722151

  • Wasserlauf J, You C, Patel R, Valys A, Albert D, Passman R. Smartwatch Performance for the Detection and Quantification of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e006834. doi: 10.1161/CIRCEP.118.006834.

    PubMed 31113234

  • Zuo S, Zhou L, Feng H, Massad C, Khalil MA, Wang J, Wang J, Zhao Y, Li F, Kong X, Jiang C, Li X, Xia S, He L, Liu X, Guo X, Zhou N, Li S, Jiang C, Tang R, Sang C, Long D, Du X, Dong J, Marrouche NF, Ma C. Validation of Smartwatches Integrated With Photoplethysmography for Continuous Evaluation of Atrial Fibrillation Burden. JACC Clin Electrophysiol. 2026 Jun 8:S2405-500X(26)00344-0. doi: 10.1016/j.jacep.2026.03.036. Online ahead of print.

    PubMed 42283663

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Atrial Fibrillation Paroxysmal, run by Beijing Anzhen Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chang Sh Ma, Dr. (86-010-64412431, chshma@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The ECG and PPG data are automatically analyzed by the AF analysis software. (time frame: Two months after enrollment of the first subject). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05333380, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.

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PPG-AF Clinical Trial NCT05333380 | AzTrials